Reducing Sedative Exposure in Ventilated ICU Patients

描述(申请人提供)：机械通气是重症监护病房(ICU)中最常用的高级生命支持方式，用于治疗各种原因引起的呼吸功能不全。为了减少焦虑、压力和提高对机械通气的耐受性，护士经常给这些患者使用镇静剂。虽然有时需要镇静，但它也不是没有严重的副作用，包括肌肉无力、精神状态改变、长时间的机械支持和长时间的ICU停留。临床实践指南建议，在使用镇静剂之前，应尝试非药物策略来减轻患者的痛苦。然而，在记录患者受益的临床试验中，非药物策略没有得到充分利用，缺乏严格的评估。音乐是一种非药物干预，它在单一治疗后显示出减少焦虑的希望，但缺乏对临床显著结果的严格评估。因此，这项临床试验的主要目的是测试患者指导的、所需的音乐干预(PDM)在减少成人机械通气患者的镇静暴露和焦虑方面的作用，并检查护理人员对呼吸机支持时间、ICU停留时间和压力调节的影响。将从中西部城市的5个ICU招募186名接受急性呼吸机支持的警觉患者作为样本，进行重复措施的3组实验设计研究。接受呼吸机支持的受试者将被随机分配到PDM、降噪耳机或接受最长30天的常规护理。镇静剂暴露(总剂量和剂量频率)、焦虑程度(视觉模拟评分和状态焦虑问卷)以及24小时尿皮质醇样本(压力)都将每天收集。主要数据分析将重复测量ANCOVA，控制疾病严重程度。这项研究的长期目标是通过加强个人控制，减少镇静剂的暴露及其严重副作用，积极影响每年接受机械通气的数百万ICU患者的重要临床结果和生活质量。

DESCRIPTION (provided by applicant): Mechanical ventilation is the most frequently used advanced, life-supportive modality in intensive care units (ICUs) to treat respiratory insufficiency from a variety of causes. To reduce anxiety, stress and promote tolerance of mechanical ventilation, nurses frequently administer sedative agents to these patients. While sedation is indicated at times, it is not without serious side effects which include muscle weakness, mental status changes, prolonged ventilatory support, and extended ICU stay. Clinical practice guidelines suggest that non-pharmacologic strategies be tried to reduce patient distress before administering sedatives. However, non-pharmacologic strategies are under-utilized and lack rigorous evaluation in clinical trials that document patient benefit. One non-pharmacologic intervention that shows promise in reducing anxiety after a single treatment but lacks rigorous evaluation on clinically salient outcomes is music. Thus, the primary aim of this clinical trial is to test a patient-directed, as desired music intervention (PDM) on reducing sedative exposure and anxiety in adult ventilated patients, and to examine attendant influences on length of ventilatory support, length of ICU stay, and stress modulation. A sample of 186 alert patients receiving acute ventilatory support will be recruited from 5 ICUs in the urban Midwest for this 3 group experimental design study with repeated measures. Subjects receiving ventilatory support will be randomized to PDM, noise- canceling headphones, or to usual care for up to 30 days. Sedative exposure (aggregate dose and dose frequency), anxiety levels (visual analog scale and State Anxiety Inventory), and 24-hour urinary cortisol samples (stress) will all be collected daily. Primary data analysis will be repeated measures ANCOVA, controlling for illness severity. Long-term objectives of this study are to positively impact important clinical outcomes and quality of life for the millions of ICU patients who experience mechanical ventilation each year by enhancing personal control while reducing exposure to sedative agents and their serious side effects.